Effectiveness of Medical and Environmental Interventions to Reduce Cystoscopy Discomfort (CystoDiscomfort)

ClinicalTrials.gov ID

NCT07795255

Lead Sponsor

Florian SchroeckFED

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 3

Enrollment

1,740Estimated

Last Update Posted

Sep 1, 2026Actual

Start Date

Nov 1, 2026Estimated

Primary Completion Date

Sep 1, 2030Estimated

Completion Date

Sep 1, 2031Estimated

Official Title

Effectiveness of Medical and Environmental Interventions to Reduce Cystoscopy Discomfort (CystoDiscomfort)

Brief Summary

The goal of this study is to learn methods doctors can use to help improve the cystoscopy experience. Specifically, this study will determine if listening to music, and the amount of time Lidocaine (a numbing medication) is allowed to rest in your urethra before beginning the cystoscopy procedure, will improve the cystoscopy experience.

Detailed Description

For patients undergoing cystoscopy who choose or do not choose to watch the procedure on a screen: Does long vs. short dwell-time lidocaine, and music vs. no music, more effectively reduce pain and anxiety and improve satisfaction and adherence to clinician recommendations for follow-up.

• Bladder (Urothelial, Transitional Cell) Cancer
• Hematuria

• Headphones
• Dwell time 5-10 minutes
• Dwell Time more than 10 minutes

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• Undergoing office-based cystoscopy for bladder cancer diagnosis, surveillance, or evaluation of anatomic abnormalities.

Exclusion Criteria:

• Allergy to or intolerance of lidocaine.
• Intolerance of all offered music genre playlists (Jazz, Classical, New Age), such that no acceptable music option exists.
• Known pregnancy or lactation (routine pregnancy testing is not required)

Primary Purpose

Supportive Care

Allocation

Randomized

Interventional Model

Factorial Assignment

Masking

None (Open Label)

Lead Sponsor

Florian SchroeckFED

dusinger@email.unc.edu

sonobia.garrett@utsouthwestern.edu

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